Trial of Juvista (Avotermin) Following Removal of Ear Lobe Keloid Scars

• ClinicalTrials.gov Identifier: NCT00469235
• Recruitment Status: Completed
• First Posted: May 4, 2007
• Last Update Posted: September 16, 2009
• Sponsor: Renovo
• Information provided by: Renovo

Tracking Information

• First Submitted Date: May 3, 2007
• First Posted Date: May 4, 2007
• Last Update Posted Date: September 16, 2009
• Study Start Date: June 2007
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 3, 2007): Frequency of adverse events [ Time Frame: 3 months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: July 7, 2008): Keloid reoccurrence [ Time Frame: 12 months ]
• Original Secondary Outcome Measures (submitted: May 3, 2007): Keloid re-occurrance [ Time Frame: 12 months ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Trial of Juvista (Avotermin) Following Removal of Ear Lobe Keloid Scars
• Official Title: A Single-centre, Double Blind, Randomised, Rising Dose Tolerance Study to Investigate the Safety of Juvista When Administered Following Excision of Ear Lobe Keloids.
• Brief Summary: This trial will assess the safety and efficacy of 50 and 200ng Juvista per linear cm of wound margin administered by intradermal injection following the excision of keloid scars on the ear lobe. Ear lobe keloids commonly occur after ear piercing and can be particularly distressing for patients as they are very difficult to conceal and are usually bilateral. As the recurrence rate and growth rate of keloids can vary significantly between individuals, trial subjects will have bilateral ear lobe keloids and will act as their own control. One ear lobe will be treated with Juvista following keloid excision and one with placebo.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Keloid

Intervention

Drug: Avotermin

10 patients:- 50ng/100μL Juvista administered by intradermal injection to each linear centimetre of one ear lobe wound margin immediately after and then 24h after wound closure versus 100 μL of placebo administered by intradermal injection to each linear centimetre of the other ear lobe wound margin immediately after and then 24h after wound closure.

10 Patients:- 200ng/100μL Juvista administered by intradermal injection to each linear centimetre of one ear lobe wound margin immediately after and then 24h after wound closure versus 100 μL of placebo administered by intradermal injection to each linear centimetre of the other ear lobe wound margin immediately after and then 24h after wound closure.

Study Arms

• Placebo Comparator: 1
  50ng dose group
  Intervention: Drug: Avotermin
• Placebo Comparator: 2
  200ng dose group
  Intervention: Drug: Avotermin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 3, 2007): 20
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 2009
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients aged 18-85 years who have given written informed consent.
• Patients with bilateral ear lobe keloid scars suitable for surgical excision which will result in a single wound on each ear lobe no greater than 2cm long and restricted to the skin, fat and fibrous tissue of the ear lobe.
• Patients with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol.
• Female patients of child bearing potential who are using a highly effective method(s) of contraception and agree to do so from at least the screening visit until one month after administration of the final study dose.

Exclusion Criteria:

• Patients who have had ear lobe keloids treated with irradiation, cryosurgery, corticosteroids, or other pharmacological agents in the three months prior to the first trial dose administration.
• Patients with a history of a bleeding disorder.
• Patients who on direct questioning and/or physical examination have past or present evidence of eczema or psoriasis local to the site of administration, uncontrolled diabetes (fasting plasma glucose concentration consistently at or above 7.0mmol 1-1 (126 mg dl-1), severely immunocompromised patients and/or malignant skin tumours e.g. melanomas, squamous or basal cell carcinomas.
• Patients with a skin disorder, not related to the keloid disease, that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial
• Patients with a history of malignancy in the last 5 years.
• Patients with a history of hypersensitivity to any of the drugs or dressings used in this trial.
• Patients who are taking, or have taken any investigational product or participated in a clinical trial in the three months prior to first trial dose administration.
• Patients undergoing investigations or changes in management for an existing medical condition.
• Patients who, in the opinion of the Investigator, are unlikely to complete the trial for whatever reason.
• Female patients who are pregnant or lactating.
• Patients with a creatinine clearance (CLcr) of 80ml/min or less.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00469235
• Other Study ID Numbers: RN1001-0064
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Renovo Ltd
• Original Responsible Party: Not Provided
• Current Study Sponsor: Renovo
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Leroy Young, MD; Body Aesthetic Plastic Surgery and Skincare Centre

• PRS Account: Renovo
• Verification Date: September 2009